药物临床试验伦理审查质量风险的管理研究

目的:为提高我国药物临床试验伦理审查质量、保障受试者权益提供参考。方法:以风险管理理论为指导,运用文献研究法、专家意见法和层次分析法对药物临床试验伦理审查流程进行梳理,提取并确定影响伦理审查质量的风险因素及其权重,并对我国药物临床试验伦理审查工作提出改进建议。结果与结论:构建的药物临床试验伦理审查风险指标体系包括5个方面共31个影响因素,其中影响药物临床试验伦理审查质量的5个方面的重要性(权重)排序依次为医学伦理委员会的自身建设(0.2635)、审查会议的管理(0.2514)、跟踪审查(0.1945)、审查申请的受理与处理(0.1892)、文件档案的管理(0.1014);权重较高的影响因素包括"讨论投票过程利益冲突人员回避(0.0787)""对方案修改、知情同意修改、严重不良事件等情形及时审查或召开会议讨论(0.0705)""明确伦理审查工作流程及时间并对外公示(0.0598)""统一、规范的审查标准与批准标准(0.0521)"等。建议可通过讨论投票环节利益冲突人员予以回避,对方案修改、知情同意修改、严重不良事件等情形及时审查或召开伦理会议讨论,明确伦理审查工作流程及时间,建立统一、规范的审查标准和批准标准等方式提高药物临床试验伦理审查的质量。     

基于层次分析法对新疆克州COPD患者危险因素的评估分析

目的：评估新疆克州慢性阻塞性肺疾病（COPD）患者的危险因素。方法：通过问卷调查的方式,收集新疆克州县级以上医院318名COPD就诊患者的一般资料、生活因素、居住因素、病因、发病诱因、临床症状等信息。运用层次分析的方法建立数学模型。结果：轻度、中度、重度患者在生活因素、居住因素、个人因素、病史等方面都存在着明显的统计学意义(P<0.01)。危险因素一级指标权重系数对比可见,个人因素（0.470）和病史因素（0.280）的权重系数最高,其次生活因素（0.136）和居住因素（0.114）。二级指标之中,个人因素方面,抽烟程度（0.231）﹥职业粉尘接触度（0.475）﹥肥胖程度（0.225）﹥经济状况（0.069）;生活因素方面,燃料清洁度（0.349）﹥厨房通风设施﹥（0.294）﹥取暖清洁度（0.266）﹥饮食烹饪清洁度﹥（0.091）;居住因素方面,住房空气质量（0.348）=住房周边环境（0.348）﹥住房通风度（0.207）﹥住房采光度（0.097）;病史因素方面,合并疾病程度（0.459）﹥既往史患病程度（0.325）﹥季节性发病程度﹥（0.149）﹥家族史患病程度（0.067）。结论：减少抽烟和职业粉尘接触,改善生活环境,提高生活质量,将有助于缓解COPD的发病。     

Analytic hierarchy process for hospital site selection

Aim: This study investigated a decision support model for site selection to establish a new hospital based on the analytic hierarchy process (AHP). The main purpose of this study was to select the best site for a hospital using this process in Mu?la, Turkey.Method: AHP was employed as the methodological tool for the selection of the site. The study was based on 6 criteria and 19 sub-criteria. All districts in the province of Mu?la were evaluated as alternatives. These districts include: Bodrum, Dalaman, Datça, Fethiye, Kavakl?dere, Koyce?iz, Marmaris, Mente?e, Milas, Seydikemer, Ula, and Yata?an. The alternatives were ranked using a 1–9 Saaty scale. The analysis of the hierarchy model was conducted by using the Super Decisions 2.2.6 software program.Results: Results show that demand is the most important factor in determining the appropriate hospital site, followed by accessibility, competitors, government, related industry and environmental conditions. According to the results, Bodrum was chosen to be the best site to establish a new hospital.Conclusion: Due to limited resources in developing countries such as Turkey, it is critical that decisions are made as a result of scientific research. In this context, investors need to take into account some factors in line with this aim. The proposed evaluation criteria provide a reference for hospital administrators and investors in the selection of hospital sites using AHP.     

A comment on the importance of numerical evaluation of analytic solutions involving approximations

An analytic solution proposed by Senn (1) for removing the effects of covariate imbalance in controlled clinical trials was subjected to Monte Carlo evaluation. For practical applications of his derivation, Senn proposed substitution of sample statistics for parameters of the bivariate normal model. Unfortunately, that substitution produces severe distortion in the size of tests of significance for treatment effects when covariate imbalance is present. Numerical-verification of proposed substitutions into analytic models is recommended as a prudent approach.     

Group marital therapy: A review

The demand for marital therapy has steadily increased as have divorce rates. Accompanying this phenomenon is the continual enquiry as to how clinicians can offer a cost-effective service for couples in distress. This paper reviews the area of group marital therapy indicating that this form of treatment is widely practised. Attention is given to the role of the therapist, the therapeutic factors operating in group marital therapy, indications and contra-indications and a brief evaluation of the research.     

‘THE LONG GOODBYE’: COGNITIVE ANALYTIC THERAPY WITH CARERS OF PEOPLE WITH DEMENTIA

This paper discusses the use of Cognitive Analytic Therapy (CAT) with carers of people with dementia and raises the wider issue of service delivery and provision of psychological therapy services to carers. Carers experience loss and emotional pain ( McCurry, 2008 ; Miesen, 2006a ; Woods et al., 2003 ) while providing full‐time care to the person with dementia who has complex and changing needs. This frequently results in major depression and anxiety, increasing the possibility of referral to mental health services. Treating carers’ distress is vital not only for their mental health but to enable them to continue in their caring role, without which the current care system would collapse. This need is being addressed in Newham by the tertiary psychology service, Psychotherapy for Older Adults (PTOA), set up in 2006–07 to accept referrals of people over 65 with mental health problems. This paper outlines how the PTOA is well placed to identify and treat carers. We propose that CAT is an effective and flexible therapy in this setting, and illustrate this with a case study. Further research and models for psychotherapeutic service delivery for carers are required.     

Prioritising public health guidance topics in the National Institute for Health and Care Excellence using the Analytic Hierarchy Process

ObjectivesThe Centre for Public Health (CPH), at the United Kingdom's National Institute for Health and Care Excellence (NICE) is responsible for producing national guidance relating to the promotion of good health and the prevention and treatment of disease. Given the challenges of developing guidance in this area, choosing the most appropriate topics for further study is of fundamental importance. This paper explores the current prioritisation process and describes how the Analytic Hierarchy Process (AHP), a multi criteria decision analysis (MCDA) technique, might be used to do so.Study designA proposed approach is outlined, which was tested in a proof of concept pilot. This consisted of eight participants with experience of related NICE committees building scores for each topic together in a 'decision conference' setting.MethodsCriteria were identified and subsequently weighted to indicate the relative importance of each. Participants then collaboratively estimated the performance of each topic on each criterion.ResultsTotal scores for each topic were calculated, which could be ranked and used as the basis for better informed discussion for prioritising topics to recommend to the Minister for future guidance. Sensitivity analyses of the dataset found it to be robust.ConclusionsChoosing the right topics for guidance at the earliest possible time is of fundamental importance to public health guidance, and judgement is likely to play an important part in doing so. MCDA techniques offer a potentially useful approach to structuring the problem in a rational and transparent way. NICE should consider carefully whether such an approach might be worth pursuing in the future.     

层次分析法在医疗设备购置进度控制中的应用

目的：运用层次分析法（AHP）缩短医疗设备购置时间,满足临床工作的迫切需要,解决需要迫切性与医疗设备购置周期长之间的矛盾。方法：建立AHP模型,列出可能影响购置时间的因素,并利用层次分析法构建两两比较判断矩阵,计算矩阵的最大特征值,最终得出制约进度的因素排序,针对排序靠前的关键因素采取节省时间的对策。结果：将对策运用到实际采购流程中,既满足了医疗设备购置流程的要求,又能够在最短的时间内完成医疗设备采购项目,满足临床工作需求。结论：采用AHP系统指导设备购置的各个环节,可显著提高医疗设备购置的效率,达到事半功倍的效果,提高设备购置管理质量。     

2005～2009年龙岩市食物中毒资料分析

[目的]了解龙岩市食物中毒发生的特点,为建立食物中毒预警体系,寻求最佳控制食物中毒发生的措施提供科学依据。[方法]对2005～2009年龙岩市食物中毒资料进行分析。[结果]2005～2009年合计发生食物中毒39起,中毒1 129人,死亡1人。39起食物中毒中,细菌性食物中毒24起、中毒982人,化学和有毒动植物性食物中毒8起、中毒29人;原因不明性食物中毒7起、中毒118人;发生起数最多的是第三季度(15起),中毒例数最多的是第三季度(607人);发生起数最多的场所是集体食堂,中毒人数最多的场所是集体食堂。[结论]龙岩市食物中毒发生起数有下降的趋势,以细菌性食物中毒为主,第三季度发生最多,主要发生在集体食堂。     

A hybrid diagnosis model for determining the types of the liver disease

The symptoms of liver diseases are not apparent in the initial stage, and the condition is usually quite serious when the symptoms are obvious enough. Most studies on liver disease diagnosis focus mainly on identifying the presence of liver disease in a patient. Not many diagnosis models have been developed to move beyond the detection of liver disease. The study accordingly aims to construct an intelligent liver diagnosis model which integrates artificial neural networks, analytic hierarchy process, and case-based reasoning methods to examine if patients suffer from liver disease and to determine the types of the liver disease.